Trius Therapeutics Announces Publication of Antibiotic Safety Study in Antimicrobial Agents and Chemotherapy
Peer-Reviewed Results Suggest No Clinically Significant Interactions Between Trius' Experimental Antibiotic Tedizolid and a Commonly Used Class of Medications
GlobeNewswirePress Release: Trius Therapeutics, Inc. – 37 minutes ago...
SAN DIEGO, June 12, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of antibiotics for serious infections, today announced the publication of the results of multiple clinical and animal studies showing the company's experimental antibiotic, tedizolid phosphate (TR-701), does not interact with monamine oxidase (MAO). MAO is an enzyme involved in the regulation of neurotransmitters such as serotonin, norepinephrine and dopamine, and its inhibition can lead to serious drug-drug interactions. These results were published in the July 2013 (Volume 57 Number 7) print issue of Antimicrobial Agents and Chemotherapy.
The findings suggest tedizolid, if approved, could potentially be taken with commonly prescribed medicines such as many antidepressants, whose use is limited with agents that inhibit MAO. Some other antibiotics are associated with rare but significant neurological adverse events when used with such agents. For example, linezolid (Zyvox(R)) exhibits drug interactions when taken with medicines that lead to increased serotonin levels, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This may cause serotonin syndrome, which is a life-threatening neurological condition. Other adverse drug reactions that may result from interactions with MAO inhibitors include hypertensive (high blood pressure) crisis caused by combination with vasoconstrictors (blood pressure medications), and hypoglycemia (low blood sugar) caused by combination with insulin or anti-diabetic medicines.
"We are encouraged that tedizolid dosed at up to 25 times above its human therapeutic use did not appear to alter MAO function in these studies," said Philippe Prokocimer, Chief Medical Officer at Trius Therapeutics. "The studies suggest that, unlike linezolid, tedizolid could be taken without restriction by patients on many common antidepressants and other medicines that inhibit MAO, subject to agreement by regulatory authorities."
Trius will include these results in its new drug application (NDA) for tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The company plans to submit the NDA to the Food & Drug Administration (FDA) in the second half of 2013.